Principal Scientist- Immunoassay
Location
Germantown, MD | United States
Job description
We are looking for a Principal Scientist to join our growing Immunoassay team in Germantown, MD. This indivdiual will be responsible for conducting contract research dealing with the impact of new biologic drug candidates on human health.
Day-to-Day
- Immunoassay development, validation and sample analysis of PK/PD, Anti-Drug Antibody (ADA) and soluble protein biomarkers in support of biologic drug development in a GLP environment or similar
- Highly experienced in flow cytometry including at least 7 color assay development and validation
- Experienced in cell-based assays including Neutralizing Antibody Assays (Nab)
- An expert in a GLP environment and all regulatory aspects associated with immunoassays used in biologic drug development
- Experienced in the use of LIMS/Watson including data downloads for reporting.
- Experienced in immunoassay platforms that include three of the following: MSD, ELISA, Luminex, Gyros, Quanterix, Ella
- Will act as a representative of Pharmaron at scientific conferences and at customer sites
- Will represent Pharmaron in professional organizations like AAPS, SOT or ASGCT and may lead subcommittees that publish industry recommendations.
- Assists in training personnel in the operation, maintenance, and troubleshooting of laboratory equipment
- Always complies with company Standard Operating Procedures unless specifically varied in the validation or sample analysis plan.
- May perform study director/PI activities such as:
- Controls appropriate bioanalytical portion of studies by designing the experimental approach, overseeing the experimental execution, collating and interpreting scientific data and generating study reports, working in close co-operation with study Sponsors at all stages.
- Carries out laboratory tasks, working with other laboratory staff to progress study-specific experimental work and, as necessary, to support non-study-specific laboratory duties.
- Prepares or reviews standard operating procedures for use by the Company, as required.
- Provides scientific and technical support to colleagues in the Business Development group, as required. This may involve participation in client visits, both inbound and outbound.
- Contributes to the training, monitoring and mentoring of staff as necessary.
- Assists with scientific investigations and efforts to troubleshoot/solve assay problems.
- Attends and presents at Scientific Conferences.
Lead development and validation of Immunoassays, cell-based assays, and/or flow cytometry as required, to detect/monitor biologics in clinical and preclinical studies associated with drug development.
Education & Experience
PhD + at least 8 years relevant immunoassay experience OR
Master of Science in relevant field + at least 11 years relevant immunoassay experience OR
Bachelor of Science in relevant field + at least 17 years relevant experience.
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